Systems and methods for delivering a medical implant to an anatomical location in a patient

ABSTRACT

Medical implant delivery devices and systems are disclosed. In general, an exemplary delivery device comprises a shaft and a handle. An exemplary system includes any number of the following: a delivery device, a sling assembly, guide members, and connectors that interconnect the above. Embodiments of all the above components and their combinations are disclosed. Methods of using the above system in trans-obturator approaches are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/776,951, filed on May 10, 2010, which is a continuation of U.S.application Ser. No. 10/957,926, filed on Oct. 4, 2004, now U.S. Pat.No. 7,713,187, which claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 60/508,600 filed on Oct. 3, 2003and U.S. Provisional Patent Application Ser. No. 60/569,300, filed onMay 6, 2004, which are hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The invention generally relates to systems and methods for delivering amedical implant to an anatomical location in a patient. Moreparticularly, in various embodiments, the invention relates to systemsand methods for employing a trans-obturator approach for delivering amedical implant to the periurethral tissue of a patient.

BACKGROUND OF THE INVENTION

Urinary incontinence (“UI”) occurs in both men and women. Various typesof incontinence are caused by different conditions and call fordifferent treatments. For example, stress urinary incontinence (“SUP”)is known to be caused by at least two conditions, intrinsic sphincterdeficiency (“ISD”) and hypermobility. One way to treat UI, both in menand women, is to place a surgical sling or suture in the periurethraltissue such as under the bladder neck or the urethra to provide aurethral platform. Placement of the sling limits mobility of the bladderneck or limits the endopelvis fascia drop while providing compressionunder event stress to improve urinary function. The sling may be affixedusing a bone anchoring method. Alternatively, an operator can use ananchorless approach to stabilize the urethra with a sling by placing thesling in the periurethral tissue and relying on tissue compression andeventual tissue in-growth to secure the sling in position.

Various transvaginal and suprapubic approaches have been used for slingplacement. However, one deficiency that such conventional proceduressuffer from is that there is some risk of puncturing the patient'sbladder.

Accordingly, devices, systems, and methods that reduce the risk ofbladder injury are advantageous,

SUMMARY OF THE INVENTION

The invention addresses deficiencies of the prior art by, in oneembodiment, providing delivery devices, systems, and methods forfacilitating delivery of an implant to an anatomical site by way of theobturator foramen. In particular, the invention provides deliverydevices, systems, and methods for placing an implant, e.g., a sling fortreating UI (including SUI), by a trans-obturator approach. In oneaspect, the invention provides a delivery device for delivering asupportive sling to the periurethral tissue of a patient via theobturator foramen of the patient.

In one embodiment, the delivery device includes a handle and a shaftextending from a distal end of the handle. The shaft may include one ormore substantially straight sections and/or one or more curved sections.In some configurations, the shaft and the handle are substantially inthe same plane. In other configurations, at least one section of theshaft and the handle are located in different planes. In someconfigurations, the shaft is located substantially in one plane. Inother configurations, the shaft includes sections located in differentplanes. Preferably, the section(s) of the shaft that extend into thepatient's body are located substantially in a single plane.

In certain embodiments, the delivery device may also include atransitional portion comprising one or more sections. The transitionalportion interfaces between a gripping section of the handle and atissue-penetrating section of the shaft. The transitional portion may beformed as part of the handle. Alternatively, the transitional portionmay be formed as part of the shaft. The transitional portion may beformed from the same material as the shaft. Alternatively, thetransitional portion may be formed from the same material as the handle.Additionally, the transitional portion may have a substantially constantdiameter along its length. Alternatively, the transitional portion mayhave a varying diameter. In some configurations, the diameter of thetransitional portion tapers as it extends axially in a distal direction.In other configurations, the diameter of the transitional portion isstepped to have sections of decreased diameter as it extends axially ina distal direction. The various sections of the shaft, the transitionalportion and the handle may locate substantially in the same plane.Alternatively, the various sections of the shaft, the transitionalportion and the handle may locate in different planes.

According to one preferred embodiment, the shaft includes an L-slot atits distal end. The L-slot may be particularly shaped to enable anassociation loop from a sling assembly to be hooked onto it during slingplacement. In one configuration the L-slot is formed from first andsecond channels. The first channel is about 2 mm in length and about 1mm in width and extends radially into the shaft. The second channel isabout 5 mm in length and about 1 mm in width and extends distally alongthe length of the shaft from an inner terminal end of the first channel.In some alternative configurations, the second channel extendsproximally, rather than distally, or in both directions from an innerterminal end of the first channel. In some configurations, the firstchannel of the L-slot extends into the shaft from a radially innerlocation along the surface of the shaft. However, in other embodiments,the first channel of the L-slot extends into the shaft from a radiallyouter surface of the shaft.

An important advantage of the L-slot configuration of the shaft is thatan association loop, when hooked onto the L-slot, remains free to slidealong the second channel. Another advantage is that, in oneconfiguration, when slid to a proximal most position in the secondchannel, the association loop may be slid radially out of the firstchannel to unhook the association loop from the delivery devices.Alternatively, according to another preferred embodiment, duringwithdrawal of the delivery device, the distally extending orientation ofthe second channel causes the association loop to slide to a distal mostposition in the second channel. This tends to maintain the associationloop hooked onto the second channel during delivery device withdrawal.

According to one aspect, the invention is directed to a system fordelivering a supportive sling to the periurethral tissue of a patient,via a trans-obturator approach. In some embodiments, the system includestwo delivery devices and a sling assembly. According to one suchembodiment, the sling assembly includes a knitted mesh and a sleeve.Each end of the sleeve connects to a dilator. Each dilator, in oneconfiguration, is a rigid polymer tube about 2 cm in length terminatingin a conical tip. The dilators act to secure the association loops, totransition from the sling assembly to the association loops, and toexpand tissue along a respective path during sling assembly placement.Embedded along the length of each dilator are two ends of a wire formedfrom twisted metal strands. The wire extends from the conical tip ofeach dilator to form an association loop. The association loop extendingfrom each conical tip is about 15 mm in length. The association loop isdeformable, but generally shape-retaining.

According to one embodiment, the knitted mesh is free floating withinthe sleeve. For one configuration of this embodiment, an opening,located at a midpoint of a top portion of the sleeve, exposes the entirewidth of the knitted mesh. Preferably, the knitted mesh is made ofpolypropylene, is about 1 cm in width and about 45 cm in length, andterminates at free ends. According to one configuration, the entirelength of the knitted mesh, including both free ends, does not connectto the sleeve or anything else. This feature enables a medical operatorto pull on the ends of the sleeve during sling assembly placement, forexample, via the dilators, the association loops, and/or the deliverydevices, without risk of stretching, curling, or otherwise deforming theknitted mesh.

According to another feature, a tabbed spacer is located at a midpointof a bottom side of the sleeve, and encloses a looped portion of thebottom side of the sleeve. The tabbed spacer can be used duringimplantation as a visual aid to placement of the knitted mesh. Thetabbed spacer also engages the looped portion of the bottom side of thesleeve and prohibits the sleeve from sliding off, or otherwise beingremoved from, the knitted mesh during sling assembly placement.Preferably, the tabbed spacer is cut to enable the sleeve to slide offthe knitted mesh. This feature ensures that the sleeve cannot be removedsimply by applying a pulling force, such as that applied to the slingassembly ends by a medical operator during sling assembly placement.After the sling assembly is positioned within the patient, a cut is madethrough the center of the tabbed spacer, and thus through the loopedportion of the bottom side of the sleeve. The sleeve is then slid off ofthe knitted mesh, out of the body of the patient, and discarded, alongwith the dilators.

According to one method of use, the shaft of a delivery device isemployed to create passages through body tissue, namely, from theinferior pubic ramus through the obturator foramen to the vagina. Threeincisions are made in the body of the patient. A first incision is madejust to the side of the edge of the ishiopubic ramus at the level of theclitoris. A second incision, corresponding to the first incision, ismade on the contralateral side. A third incision is made in the anteriorvaginal wall. The delivery device is held by the handle with one handand is inserted through one ishiopubic incision in a downward motion,piercing the obturator muscle and obturator membrane. Then, the handleis turned to a position about 45 degrees to the vertical midline of thepatient's body. A forefinger of the other hand is placed in the vaginalincision and on the distal end of the delivery device. The forefinger isused to guide the distal end around the ishiopubic ramus through thevaginal incision.

Next, the first association loop is slid over the distal end of theshaft of the delivery device and radially into the first channel of theL-slot. The association loop is then moved distally away from thedelivery device within the second channel to hook one end of the slingassembly onto the delivery device. The delivery device is then withdrawnfrom the ishiopubic incision, drawing the end of the sling assemblythrough the passage created by the shaft. The orientation of the L-sloton the shaft with respect to the ishiopubic approach ensures that theassociation loop is tensioned toward the closed, distal end of theL-slot as the delivery device is withdrawn. Subsequent to withdrawal,the association loop is unhooked from the delivery device. This processis repeated with the same or a second delivery device and the secondassociation loop on the contralateral side of the body. Optionally, asingle cystoscopy may be performed with two delivery devices in place,prior to withdrawal of the delivery devices to verify integrity of thebladder. Cystoscopy may also be performed, as desired, after eachplacement of a delivery device on a side of the body. Alternatively,cystoscopy may be performed after withdrawal of both delivery devices.

According to another method of use, the shaft of a delivery devicecreates passages through body tissue from the vagina through theobturator foramen and through the inferior pubic ramus. Once again,three incisions are made in the body of the patient. A first incision ismade just to the side of the edge of the ishiopubic ramus at the levelof the clitoris. A second incision, corresponding to the first incision,is made on the contralateral side. A third incision is made in theanterior vaginal wall. In this procedure, the L-slot is positioned withthe second channel extending proximally along the shaft, rather thandistally, and the first association loop is hooked into the L-slot atthe distal end of the shaft of the delivery device prior to insertinginto the patient. The delivery device is inserted through the vaginalincision in a lateral motion passing behind the ishiopubic ramius, andpiercing the obturator membrane and the obturator muscle and exiting theishiopubic incision. The delivery device can be unhooked from firstassociation loop and withdrawn from the body. This process is repeatedwith the same or a second delivery device and the second associationloop on the contralateral side of the body. Optionally, a singlecystoscopy may be performed with two delivery devices in place, prior towithdrawal of the delivery devices to verify integrity of the bladder.Cystoscopy may also be performed, as desired, after each placement of adelivery device on a side of the body. Alternatively, cystoscopy may beperformed after withdrawal of both delivery devices.

Other movements may be employed, wherein the delivery device is firstinserted into a vaginal incision, through the obturator membrane and theobturator muscle, and exiting from a ishiopubic.

The dilators may be used as handles to adjust the position of the slingassembly to achieve desired placement. Once desired placement of thesling assembly is achieved, the tabbed spacer, and thus the loopedportion of the bottom side of the sleeve, may be cut. Then, by pullingupward on the dilators, the medical operator can slide the sleeve offthe knitted mesh and remove it from the body. The delivery devices andthe sleeve, including the dilators, can then be discarded.

In a variation of this approach, the delivery devices do not include anyL-slots and the sling assembly includes a guide tube extending from eachend of the sling assembly in place of the association loops. In such aconfiguration, the shaft of each respective delivery device can beinserted into a respective guide tube at the end of the guide tubeclosest to the sling assembly. According to one method, the vagina toishiopubic methodology is employed, rather than the ishiopubic incisionto vagina methodology, and subsequent to the distal end of a shaftexiting the ishiopubic incision, a medical operator grasps the end ofthe guide tube, for example, with forceps and withdraws the deliverydevice.

According to one aspect, the shaft of a delivery device includes asubstantially straight section, a curved section and a transitionalportion, all lying substantially in a single plane. The transitionalportion includes a first and a second substantially straight sectionsand a curved section. The first substantially straight section of thetransitional portion attaches to a distal end of the handle, extendsdistally along a first axis, and preferably has a substantially constantdiameter. The curved section of the transitional portion extends from adistal end of the first straight section of the transitional portion,curves away from the first axis, and also preferably has a substantiallyconstant diameter. The second substantially straight section of thetransitional section extends from a distal end of the curved section ofthe transitional portion along a second axis, and preferably has anoutside diameter that decreases from its proximal end to its distal endto provide increased structural stability to the shaft. The curvedsection of the shaft preferably has a substantially constant diameter,extends from the distal end of the transitional portion, curves backtoward the first axis, and terminates at a distal end approximately atan intersection with the first axis. The substantially straight sectionof the shaft preferably has a substantially constant diameter, andextends from the distal end of the curved section of the shaft along athird axis, which crosses the first axis. The substantially straightsection of the shaft terminates at a distal end to form a conical tip.The transitional portion may be formed from the same materials as theshaft, or alternatively, from the same material as the handle.Preferably, the shaft is formed of surgical grade stainless steel. In apreferred embodiment, only the curved section and the substantiallystraight section of the shaft penetrate into the body of a patientduring sling placement.

In another aspect, the shaft includes a first straight section extendingalong an axis distally from the distal end of the handle and a firstcurved section, which initially curves away and then back across theaxis of the first straight section. The shaft also includes a secondcurved section, in one configuration, having a radius larger than theradius of the first curved section. Like the first curved section, thesecond curved section initially curves away from and than back towardthe axis of the first straight section. A second straight sectionextends from a distal end of the second curved section. In someconfigurations, the second straight section may or may not ultimatelycross the axis of the first straight section. As in the case ofpreviously discussed embodiments, the shaft may terminate in a conicaltip, and may include an L-slot at its distal end for associating with asling assembly or other medical implant. One advantage of having the tipextend across the axis of the first straight section is that it providesincreased ease with which the medical operator can puncture through theobturator membrane in a trans-obturator approach, and reduces thelikelihood of the handle getting in the way. Additionally, the apex ofthe curve having the smaller radius can act as a fulcrum to enable thephysician to have more control when inserting the shaft.

In some multiple curve embodiments, the first curved section extendsfirst distally along a longitudinal axis of the handle, then reversesdirection to extend back proximal of the distal end of the handle. Thesecond curved section then curves the shaft back in a distal direction.

In another aspect of the invention, a first section of the handle of thedelivery device extends along a first axis substantially in a firstplane. A second section of the handle extends distally from, but along asecond axis at an angle to, the first axis, which is substantially inthe same plane as the first section of the handle. In one configuration,a shaft having a curved section first extends out of the first plane ofthe first and second handle sections, then extends back toward the firstplane. In some configurations, the distal tip of the shaft extends backthrough the first plane. In other configurations, the distal tip extendsup to or short of the first plane. In a related embodiment, the deliverydevice also includes a transitional portion having one or more sectionslocated substantially in the first plane and extending between thehandle and the curved section of the shaft for providing addedstructural support to the curved section of the shaft and/or forfacilitating interconnection between the curved section of the shaft andthe distal end of the handle. In one configuration, the transitionalportion includes the second section of the handle and a substantiallystraight section of the shaft. In a preferred embodiment, the one ormore transitional sections do not penetrate into the body tissue of apatient during sling placement.

According to one feature, the shaft rotates about an axis that issubstantially orthogonal to the first plane. According to otherfeatures, the axis need not be substantially orthogonal to the firstplane. In some configurations, the axis is in a second plane parallel tothe first plane. According to another embodiment, the at least one ofthe first and second sections of the handle tapers to be narrower as thehandle extends distally toward the shaft.

In a further aspect of the invention, a first section of the shaft ofthe delivery device extends out of the handle along a first axissubstantially in a first plane. A section of the shaft extends distallyfrom, but at an angle to the first section of the shaft, andsubstantially in the same plane as the first section of the shaft. Athird shaft section including a curved portion first extends out of thefirst plane of the first and second shaft sections, then extends backtoward the first plane. In some configurations, the distal tip of theshaft extends back through the first plane.

In other configurations, the distal tip extends up to or short of thefirst plane. According to one embodiment, the third shaft section is ina plane that is substantially orthogonal to the axis of the first shaftsection. However, in other embodiments, the plane is at a non-orthogonalangle to the axis of the first shaft section.

In various aspects of the invention, some sections of the shaft aremoveable relative to other sections of the shaft. By way of example, insome embodiments a portion of the shaft can be manipulated or rotatableabout an axis of the handle. The rotation can be used, for example, toadjust for a patients anatomy and/or to improve operator ergonomics.According to one configuration, the rotation encompasses up to about 360degrees about an axis defined by the connection point between the shaftand the handle. By rotating the curved shaft, for example, up to about180 degrees (e.g., up to, for example, 90 degrees about an axis, andfrom either side of the plane of the handle), the delivery device can beadapted for use on a lateral side and on a contralateral side of thepatient.

According to other embodiments, a portion of the shaft can be tilted,for example up to about 90 degrees relative to the axis of the handle.In one construction, the delivery devices include discrete lockinglocations, for example, at about 0, 30, 45, 60 and/or 90 degreesrelative to the axis of the handle. In other embodiments, a portion ofthe shaft extends distally out of the handle along an axis, and anotherportion of the shaft can be rotated about and/or tilted relative to theaxis of the portion extending out of the handle. Preferably, afterrotation and/or tilting to a desired position, the shaft may be securedat such a position relative to the handle. Any suitable mechanism may beemployed for achieving such rotation, tilting, and/or locking.

The handle of a delivery device may be of various configurations. Inpreferred embodiments, the handle is of an ergonomic design andconstruction that reduces operator fatigue and discomfort, providesneeded leverage and gripping surface for the user, orients the user asto the direction of the shaft, and/or provides fingertip or palm controlover the shaft. The handle may, for example, be cylindrical. Crosssections of the handle may have variable diameters, for example, atleast one portion of the handle may have a cross section that is smallerthan the adjacent portions of the handle to provide grooves for anoperator to hold the handle. Alternatively, the cross section of ahandle has a decreasing area from the proximal end to the distal end ofthe handle. The handle may have a substantially hexagonal cross section.Alternatively, the handle may be substantially T-shaped, D-shaped orkidney-shaped. Alternatively, the handle may be a ratchet type.

Additional features and advantages of the invention will be apparentfrom the following description of preferred embodiments and from theclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures depict certain illustrative embodiments of theinvention in which like reference numerals refer to like elements. Thesedepicted embodiments may not be drawn to scale and are to be understoodas illustrative of the invention and not as limiting in any way.

FIG. 1 is a side view of a delivery device according to an illustrativeembodiment of the invention.

FIG. 2 is a perspective side view of a delivery device having a shaftwith a curved section according to another illustrative embodiment ofthe invention.

FIG. 3 depicts a delivery device having a shaft with a curved portiontilted at about ninety degrees relative to an axis of its handleaccording to another illustrative embodiment of the invention.

FIG. 4 depicts a delivery device having a shaft with a curved portionthat extends through more than one plane according to anotherillustrative embodiment of the invention.

FIG. 5 is a side view of a delivery device having a shaft with a sectionthat can be adjustably tilted relative to an axis of a handle accordingto an illustrative embodiment of the invention.

FIGS. 6A-6C depict an exemplary mechanical configuration for providingthe adjustable tilting features of the illustrative delivery device ofFIG. 5.

FIG. 7 is a perspective side view of a delivery device including twooppositely curving shaft sections according to an illustrativeembodiment of the invention.

FIG. 8 is a perspective side view of a delivery device having a shaftwith a section that curves proximally back toward its handle accordingto an illustrative embodiment of the invention.

FIGS. 9A-9C depict various views of a delivery device having a shaftwith coplanar straight sections and a partially spiralled sectionaccording to another illustrative embodiment of the invention.

FIGS. 10A-10C depict a delivery device having a shaft with twosubstantially straight sections located in a first plane and angledrelative to each other, and a curved section located in a second planeaccording to an illustrative embodiment of the invention.

FIGS. 11A-11D depict a delivery device having a shaft with twosubstantially straight sections located in a first plane and angledrelative to each other, and a curved section located in a second planeat substantially a right angle to the first plane according to anillustrative embodiment of the invention.

FIGS. 12A and 12B depict a pair of delivery devices having an angledhandle located in a first plane and a shaft having a curved sectionlocated in a second plane.

FIGS. 13A-13C depict various views of a delivery device having a handlewith first and second substantially straight sections locatedsubstantially in a first plane and angled relative to each other, ashaft having a curved section located substantially in a second plane,and a transitional section extending between a distal end of the handleand a proximal end of the curved section of the shaft according to anillustrative embodiment of the invention.

FIG. 14 depicts a variation of the illustrative embodiment of FIGS.13A-13C, wherein the handle includes an alternative extendedstructurally reinforced portion in replacement for the second straighthandle section and the transitional section of the embodiment of FIGS.13A-13C.

FIG. 15 depicts another variation of the illustrative embodiment of FIG.14, wherein the first and second structurally reinforcing handlesections are replaced with unreinforced first and second substantiallystraight shaft sections.

FIGS. 16A-16D depict another variation of the illustrative embodiment ofFIGS. 13A-13C, wherein the handle includes first, second, and thirdextended structurally reinforcing handle sections in replacement for thestructurally reinforcing handle sections of FIG. 14.

FIG. 17 depicts a delivery device including a button-like protrusion onan extended structurally reinforcing section of the handle to provide afinger hold for a medical operator according to an illustrativeembodiment of the invention.

FIG. 18 depicts a variation of the delivery device of FIG. 17 includingan alignment post according to another illustrative embodiment of theinvention.

FIG. 19 depicts an alternative view of the delivery device of FIG. 18illustrating an alignment hole in the alignment post for positioning adistal end of the shaft relative to a patient according to anillustrative embodiment of the invention.

FIGS. 20A-20D depict various views of an exemplary sling assembly of thetype that may be employed in an illustrative embodiment of theinvention.

FIG. 21 is a longitudinal cross sectional view of a dilator and anassociation loop according to an illustrative embodiment of theinvention.

FIG. 22 is a side view of an L-slot in a distal end of a shaft of adelivery device according to an illustrative embodiment of theinvention.

FIG. 23 depicts a sling assembly including guide tubes according toanother illustrative embodiment of the invention.

FIGS. 24A and 24B depict a shaft of a delivery device inserted into aguide tube according to two different illustrative embodiments.

FIGS. 25A-25C depict two illustrative trans-obturator approaches.

ILLUSTRATIVE DESCRIPTION

As described in summary above, the invention, in one illustrativeembodiment, relates to systems and methods for delivering and placing amedical implant at an anatomical site in the body of a mammal. Inparticular, in various illustrative examples, the invention providesdelivery devices, systems, and methods for placing an implant, e.g., asling for treating UI (including SUI), by a trans-obturator approach. Inone aspect, the implant includes a supportive sling and is delivered tothe periurethral tissue of a patient via the obturator foramen. In oneembodiment, the delivery device includes a handle and a shaft extendingfrom a distal end of the handle. The patient may be either a femalepatient or a male patient.

Without limitation, examples of slings, sling assemblies, deliverydevices and implantation approaches that may be employed with respect tosome features of illustrative embodiments of the invention are disclosedin U.S. Pat. No. 6,666,817, entitled “Expandable surgical implants andmethods of using them,” U.S. Pat. No. 6,669,706, entitled “Thin softtissue surgical support mesh,” U.S. Pat. No. 6,375,662, entitled “Thinsoft tissue surgical support mesh,” U.S. Pat. No. 6,042,592, entitled“Thin soft tissue surgical support mesh,” U.S. patent application Ser.No. 10/015,114, entitled “Devices for minimally invasive pelvicsurgery,” U.S. patent application Ser. No. 10/774,826, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/093,398, entitled “System for implanting an implant and methodthereof,” U.S. patent application Ser. No. 10/093,498, entitled “Systemfor implanting an implant and method thereof,” U.S. patent applicationSer. No. 10/093,371, entitled “System for implanting an implant andmethod thereof,” U.S. patent application Ser. No. 10/093,424, entitled“System for implanting an implant and method thereof,” U.S. patentapplication Ser. No. 10/093,450, entitled “System for implanting animplant and method thereof,” U.S. patent application Ser. No.10/094,352, entitled “System for implanting an implant and methodthereof,” U.S. patent application Ser. No. 10/631,364, entitled“Bioabsorbable casing for surgical sling assembly,” U.S. patentapplication Ser. No. 10/641,376, entitled “Spacer for sling deliverysystem,” U.S. patent application Ser. No. 10/641,487, entitled “Systems,methods and devices relating to delivery of medical implants,” U.S.patent application Ser. No. 10/642,395, entitled “Systems, methods anddevices relating to delivery of medical implants,” U.S. patentapplication Ser. No. 10/642,397, entitled “Systems, methods and devicesrelating to delivery of medical implants,” U.S. patent application Ser.No. 10/832,653, entitled “Systems and methods for sling delivery andplacement,” the entire contents of all of which are incorporated hereinby reference.

The invention addresses deficiencies of the prior art by, in variousillustrative embodiments, providing delivery devices, systems, andmethods for placing an implant, e.g., sling for treating UI (includingSUI), by a trans-obturator approach. As described below in furtherdetail, the illustrative delivery devices include a handle and a shaftextending from a distal end of the handle. The shaft may include one ormore substantially straight sections and/or one or more curved sections.In some configurations, the shaft and the handle are substantially inthe same plane. In other configurations, at least one section of theshaft and the handle are located in different planes. In someconfigurations, the shaft is located substantially in one plane. Inother configurations, the shaft includes sections located in differentplanes. Preferably, the section(s) of the shaft that extend into thepatient's body are located substantially in a single plane. The shaftmay be, for example, any suitable needle, cannula, tubular member,tunneler, dilator, or the like. In a similar fashion, the handle mayinclude sections located in different planes.

In certain embodiments, the delivery device may also include atransitional portion comprising one or more sections. The transitionalportion interfaces between a gripping section of the handle and atissue-penetrating section of the shaft. The transitional portion may beformed as part of the handle. Alternatively, the transitional portionmay be formed as part of the shaft. The transitional portion may beformed from the same material as the shaft. Alternatively, thetransitional portion may be formed from the same material as the handle.Additionally, the transitional portion may have a substantially constantdiameter along its length. Alternatively, the transitional portion mayhave a varying diameter. In some configurations, the diameter of thetransitional portion tapers as it extends axially in a distal direction.In other configurations, the diameter of the transitional portion isstepped to have sections of decreased diameter as it extends axially ina distal direction. The various sections of the shaft, the transitionalportion and the handle may locate substantially in the same plane.Alternatively, the various sections of the shaft, the transitionalportion and the handle may locate in different planes.

Preferably, the shaft is formed from a metal or a polymeric material.Examples of suitable metals include, but are not limited to, stainlesssteel, titanium, and alloys such as nitinol. Suitable polymers, whichcan be used as a coating on a metal to form the shaft, include but arenot limited to, plastics such as polytetrafluoroethylene (PTFE). In someconfigurations, the shaft is rigid. However, in other configurations,the shaft has some flexibility, and can be described as semi-rigid. Theshaft may have a conical tip at the distal end. The conical tip mayconfigured for percutaneous punctuation and/or advancement throughtissue. However, the tip may be blunt or sharp. A blunt tip providessome resistance to unintended penetration through tissue or organ, suchas the bladder.

The shaft may be solid or hollow. If the shaft is at least partlyhollow, it may include a lumen (not shown) that has one or more openingson the shaft, for example, at the distal tip or along the side of theshaft. The cross-section of the shaft may have a constant shape andsize, or its shape and/or size may vary along its length. Thecross-section of the shaft may assume any suitable shape, for example,circular, semi-circular, oval, triangular, or rectangular. In otherembodiments, the distal end may include an enlarged, flared portion todilate tissue beyond the nominal diameter of the shaft.

In one illustrative embodiment, the surface of the shaft is smooth andmay be coated with one or more drugs such as anesthetic,anti-inflammatory, coagulating, anticoagulating, antibiotic, orantimicrobial agents. The drug may be delivered to the patient's tissuewhile the shaft is in contact with the tissue. The surface of the shaftmay be coated with a light-absorbing coating to reduce glare, forexample, under a cystoscope. The coating may be a polymer, such asTeflon, or other suitable material, and may be colored to aid indetection. The surface of the shaft may be painted so that one caneasily tell it apart from surrounding tissue and fluid under acystoscope to make it easier to detect under the cystoscope. In otherillustrative embodiments, the shaft is textured, for example, bystippling, to provide increased traction relative to a gloved hand of amedical operator. In another illustrative embodiment, the shaft isfitted with a colored sheath, such as a blue plastic sheath or a guidetube.

FIG. 1 depicts a side view of a delivery device 10 according to anillustrative embodiment of the invention. The delivery device 10includes a handle 12, a shaft 14, and a transitional portion extendingdistally between a distal end 12 a of the handle 12 and a proximal endof the shaft 14. The transitional portion 17 includes a first straightsection 17 a, a curved section 17 b and a second straight section 17 call lying substantially in as single plane, and may be formed as eitherpart of the shaft 14 or as part of the handle 12. The shaft 14 includesa curved section 14 a, a straight section 14 b and a conical tip 14 c,all lying substantially in the same plane as the transitional portion17. In the illustrative embodiment, the first straight section 17 a ofthe transitional portion 17 attaches to the distal end 12 a of thehandle 12, extends distally along a first axis 11, and preferably has asubstantially constant diameter. The curved section 17 b of thetransitional portion 17 extends from a distal end of the first straightsection 17 a, curves away from the first axis 11, and also preferablyhas a substantially constant diameter. The second straight section 17 cextends from a distal end of the curved section 17 b along a second axis13, and preferably has a diameter that decreases from its proximal endto its distal end to provide increased structural stability to the shaft14. The curved section 14 a, preferably, has a substantially constantdiameter, smaller than the diameter of the curved section 17 b of thetransitional portion 17, and extends from the distal end of the secondstraight section 17 c of the transitional portion 17, curves back towardthe first axis 11, and terminates at a distal end approximately at anintersection with the first axis 11. The straight section 14 b,preferably, has a substantially constant diameter and extends from thedistal end of the curved section 14 a along a third axis 15, whichcrosses the first axis 11. A conical tip 14 c extends distally from thestraight section 14 b. As discussed below in further detail with regardto FIG. 22, the distal end 19 of the delivery device 10 may include astructure for associating the delivery device 10 with a sling assembly.Preferably, the shaft 14 is formed of surgical grade stainless steel.

FIG. 2 depicts a perspective side view of a delivery device 20 accordingto another illustrative embodiment of the invention. The delivery device20 includes a shaft 24 and a handle 22. The handle 22 includes a baseportion 22 a and a handle extension/transitional portion 22 b. The shaftincludes a first straight section 24 a extending axially from aconnection location 23 in the handle extension/transitional portion 22b, a curved section 24 b extending from a distal end of the firststraight section 24 a, a second straight section 24 c extending from adistal end of the curved section 24 b, and a conical tip 26 extendingfrom a distal end of the second straight section 24 c. The shaft 24 hasa substantially C shape. As depicted, the shaft 24, the handleextension/transitional portion 22 b, and the handle base 22 a are allsubstantially coplanar. According to the illustrative embodiment of FIG.2, the distal end of the shaft 24 crosses the axis 27 of the handle 22.More particularly, the curved section 24 b falls short of the axis 27,but the second straight section 24 c crosses it. In other embodimentsthe distal most ends of the conical tip 26, the second straight section24 c or the curved section 24 b may extend past, fall short of or extendup to the axis 27.

FIG. 3 depicts a delivery device 30 according to another illustrativeembodiment of the invention. The delivery device 30 includes a shaft 34and a handle 32. The handle 32 includes a base portion 32 a and a handleextension/transitional portion 32 b. The shaft 34 extends from aconnection location 36 in the handle extension/transitional portion 32b, is shaped in a similar fashion to the Shaft 24 of FIG. 2 and includesa first straight section 34 a, a curved section 34 b, a second straightsection 34 c and a conical tip 38. The shaft 34 is rotated approximately90 degrees about the axis 31 of the first straight section 34 to tiltthe curved section 34 b of shaft 34 about 90 degrees relative to theaxis 33 of the handle 32.

FIG. 4 depicts a delivery device 40 having a shaft 44 and a handle 42.As in the case of the illustrative embodiments of FIGS. 2 and 3, thehandle 42 includes a base portion 42 a and a handleextension/transitional portion 42 b. The shaft 44 extends radially outof the connection location 43 in the handle extension/transitionalportion 42 b. Unlike the illustrative embodiments of FIGS. 2 and 3, thecurved section 44 b extends distally around the axis 45 of the handle 42to form a portion of a spiral.

FIG. 5 is a side view of a delivery device 40 having a shaft 54 and ahandle 52. The handle 52 has a base portion 52 a and a handle extension52 b. The shaft 54 can be rotated by a medical operator in a controlledfashion through an angle 55 about a pivot 58 located at a distal end ofthe handle extension/transitional portion 52 b to tilt the shaft 54relative to an axis 57 of the handle 52. The shaft 54 is similarlyshaped to the shaft 44 of FIG. 4. However, any suitably shaped shaft maybe employed. Additionally, the pivot 58 is depicted as being located onthe handle extension/transitional portion 52 b, it may alternatively belocated along the shaft 54, enabling a portion of the shaft 54 to bepivoted relative to another, for example, stationary portion of theshaft 54. According to the illustrative embodiment, the shaft may bepivoted through an angle of at least about 30, 60, 90, 120, 180, or upto about 360 degrees, or any degree of angle in between, limited inpivot only by contact with the handle on either side of the axis of thehandle. Also, rather than being pivotable about the pivot 58, asindicated by the arrow 59, the shaft 54 or a portion of the shaft 54 mayalso or alternatively rotate radially about the axis 57. According tothe illustrated embodiment, the shaft 43 may be rotated in either aclockwise or counter clockwise direction and through an angle of atleast about 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, or 360degrees. Shaft pivoting and/or rotation may be continuous in nature, forexample, using a set screw to lock the shaft in place. Alternatively, itmay be discrete in nature, for example, with gears, cogs, engagingsurfaces or the like defining allowable shaft positions. A discreteconfiguration, for example, may have a spring loaded user-actuatablecomponent to enable a medical operator to adjust the shaft position adesired.

FIGS. 6A-6C depict an exemplary delivery device 60 including amechanical configuration for providing the adjustable pivoting featuresof the illustrative delivery device 50 of FIG. 5. The delivery device 60includes a shaft 64 and a handle 62. The handle 62 includes a baseportion 62 a and a handle extension/transitional portion 62 b. Thedelivery device 60 also includes a pivot control mechanism 65. The pivotcontrol mechanism 65 includes a housing 65 a and features 65 b on thehandle extension/transitional portion 62 b. As shown in FIG. 6B, astraight section 64 a of the shaft 64 extends radially through thehousing 65 a. In operation, the housing 65 a rotates about a pivot 63. Aspring 68 loaded set screw 69 provides a mechanism for locking the shaft64 in place. In alternative embodiments, the set screw 69 is calibratedso that the spring 68 is not fully compressed, and a medical operatorcan pull on the shaft 64 in the direction indicated by the arrow 61 todisengage the housing 65 a from the features 65 b and enable shaftpivoting. According to this embodiment, to lock the shaft 64 in place,the medical operator ceases pulling the shaft 64 in the directionindicated by the arrow 61, enabling the housing 65 a and the features 65b to re-engage. Optionally, the set screw 69 can then be tightened tofully compress the spring 68 to ensure that the housing 65 a is lockedin place relative to the features 65 b.

As mentioned above, in some illustrative embodiments, a shaft of theinvention includes multiple curved sections. FIG. 7 depicts a deliverydevice 70 according to one such illustrative embodiment. The deliverydevice 70 includes a handle 72 and a shaft 74 extending distally from adistal end of the handle 72. According to this illustrative embodiment,the shaft includes a first straight section 74 a extending distally fromthe distal end of the handle 72 along a longitudinal axis 74 of thehandle 72. The shaft 74 also includes a first curved section 74 b, whichinitially curves away and then back across the axis 71. A second curvedsection 74 c, in one configuration, having a radius 77 larger than theradius 75 of the first curved section 74 b, extends from a distal end ofthe first curved section 74 b and initially curves away from and thanback toward the axis 71. In the illustrative embodiment, a secondstraight section 74 d extends from a distal end of the second curvedsection 74 c. In various illustrative embodiments, the second straightsection 74 d may or may not ultimately cross the axis 71. According toone illustrative embodiment the tip 78 of the shaft 74 extends, forexample, about 0.3 inches, about 0.3-1.0 inches, or about 0.54-0.75inches past the axis 71. As in the case of previously discussedembodiments, the shaft 74 may terminate in a conical tip 78 and mayinclude an L-slot at its distal end for associating with a slingassembly or other medical implant. One advantage of having the tip 78closer to the patient is increased ease with which the shaft 74 canpuncture through the obturator membrane in a trans-obturator approach.Another advantage is that it reduces the likelihood of the handlegetting in the way. Moreover, the apex of the small radius 75 can act asa fulcrum, which enables a medical operator to have more control wheninserting the shaft.

FIG. 8 is a perspective side view of a delivery device 80 having ahandle 82 and shaft 84 extending distally from a distal end of thehandle 82. The handle 82 is ergonomically shaped, having a T-likeconfiguration. The handle 82 has a width 81 that tapers to reduce thewidth 81 as the handle 82 extends from a proximal end to a distal end.The proximal end of the handle 82 includes a T-like feature 82 a. Thehandle also includes a section 82 b that is raised relative to the otherhandle sections 82 a and 82 c. The handle 82 also includes a texturedportion 87 that further facilitates gripping of the delivery device 80.The shaft 84 includes a first straight section 84 a that extendsdistally from a distal end of the handle 80 along a longitudinal axis 89of the handle 80. A first curved section 84 b first curves distallyalong the axis 89 then curves proximally back toward the handle 82, anda second curved section 84 c then curves the shaft 84 back in a distaldirection. The shaft 84, illustratively, terminates in a conical tip 86.The first 84 b and second 84 c curved shaft sections may or may not besubstantially co-planar with each other and/or with the handle 82.

FIGS. 9A-9C depict various views of a delivery device 100 having a shaft104 and a handle 102. The handle 102 is shaped similarly to the handle82 of FIG. 8. The shaft 104 includes a first straight section 104 aextending distally from the distal end of the handle 102 along alongitudinal axis 101 of the handle 102. The first straight section 104a of the shaft 104 is substantially coplanar in a first plane with thehandle 102. A second straight section 104 b of the shaft 104 extendsdistally from, but at an angle to the first straight section 104 a. Inthe illustrative embodiment, the second straight section 104 b is alsosubstantially coplanar with the handle 102. A first curved section 104 cof the shaft 104 extends from a distal end of the second straightsection 104 b and curves that shaft back toward the axis 101. A thirdstraight section 104 d of the shaft 104 extends from a distal end of thefirst curved section 104 c. The first curved section 104 c and the thirdstraight section 104 d are substantially coplanar with each other in asecond plane. According to this illustrative embodiment, the first planeof the handle 102 and the second plane of the curved section 104 c areangled relative to each other and are not the same plane. The shaftsection of the delivery device 100 may be of constant cross sectionaldiameter or may have differing cross sectional diameters. Additionally,the shaft sections my have tapered cross sectional diameters to make forsmooth surface transitions from one shaft section to the next. Asdepicted, the illustrative delivery device 100 terminates in a conicaltip 106. However, this need not be the case, as any suitable tip may beemployed. It should be noted that dimensions shown in FIGS. 9A-9B areall given in centimeters, are illustrative in nature, and are notintended to be limiting with regard to possible dimensions.

FIGS. 10A-10C depict various views of a delivery device 110 having ashaft 112. The shaft 112 is configured similarly to the shaft 104 ofFIG. 9. More particularly, the shaft 112 includes a first straightsection 112 a extending distally along a longitudinal axis 111. A secondstraight section 112 b of the shaft 112 extends distally from, but at anangle to the first straight section 112 a. In the illustrativeembodiment, the second straight section 112 b is substantially coplanarin a first plane with the first straight section 112 a. A first curvedsection 112 c of the shaft 112 extends from a distal end of the secondstraight section 112 b and curves the shaft 112 back toward the axis111. A third straight section 112 d of the shaft 112 extends from adistal end of the first curved section 112 c. The first curved section112 c and the third straight section 112 d are substantially coplanarwith each other in a second plane. As in the case of the embodiment ofFIGS. 9A-9C and as shown in FIG. 10B at 115, the first plane of thefirst 112 a and second 112 b straight sections and the second plane ofthe curved section 104 c are angled relative to each other and are notthe same plane. However, rather than the variable radius curve of thecurved section 104 c, as depicted in FIG. 9C, the curved section 112 cdefines a substantially constant radius curve.

FIGS. 11A-11D depict a delivery device 120 configured as a variation ofthe illustrative delivery device 110 of FIGS. 10A-10C. Moreparticularly, the shaft sections 122 a-122 d are arranged such that theangle 121 between the plane of the first 122 a and second 122 b straightsections and the plane of the curved section 122 c are substantiallyorthogonal to each other. Variations on the orientation of the (1) astplane and the second plane, (2) the angle between the shaft straightsections, and/or (3) the angle between the curved shaft section and theadjacent shaft straight section, other than is shown here with respectto the devices in FIGS. 10-16, are contemplated as desired to optimizethe movement that is used during a particular procedure. A handleassociated with the device may extend over a portion of or the entiretyof shaft section 122 a and section 122 b. Preferably, curved section 122c is the only portion of the shaft that penetrates into a patient'sbody.

FIGS. 12A and 12B depict a pair of delivery devices 130 a and 130 b,each having an angled handle, according to another illustrativeembodiment of the invention. The devices 130 a and 130 b aresubstantially mirror images of each other for ease of use on either sideof a patients body. Accordingly, for illustrative purposes, only FIG.12A is discussed. The handle 135 of the delivery device 130 a includes afirst section 132 a extending along a first longitudinal axis 131substantially in a first plane. A second section 134 a of the handle 135extends distally from, but at an angle 137 to, the axis 131 of the firstsection 132 a. The first 132 a and second 134 a sections of the handle135 are substantially coplanar in the first plane. A shaft 136 aincludes a curved section 139 a that extends from a mounting location129 a at a distal end of the second handle section 134 a. The curvedsection 139 a first extends out of the first plane of the first 132 aand second 134 a handle sections, then extends back toward the firstplane. In some configurations, the distal tip 138 a (conically shaped inthe illustrative embodiment) of the delivery device 130 a extends backthrough the first plane. In other configurations, the distal tip 138 aextends up to or short of the first plane. According to one feature, theshaft 136 a rotates about an axis 127 that is substantially orthogonalto the first plane. However, according to other illustrativeembodiments, the axis 127 need not be substantially orthogonal to thefirst plane. According to alternative illustrative embodiment, at leastone of the first 132 a and second 134 a sections of the handle 135tapers to have a narrower width 125 as the handle 135 extends distallytoward the shaft.

FIGS. 13A-13C depict various views of a delivery device having a handle142 with first 142 a and second 142 c substantially straight sectionslocated substantially in a first plane and angled relative to each otherat 142 b, a transitional portion 145 extending out of a distal end 143of the handle 142, and a shaft 144 extending from a distal end of thetransitional portion 145. The shaft includes curved section 144 a, astraight section 144 b, and terminates in a conical tip 144 c.

The transitional portion 145 interfits and extends axially out of thedistal end 143 of the second handle section 142 c to affix the shaft 144to the handle 142. As a result, the transitional portion 145 issubstantially co-planar with the handle 142 in the first plane. Thecurved section 144 a of the shaft 144 is shaped substantially like thecurved section 122 c of FIG. 11 and extends from a distal end of thetransitional portion 145. The straight section 144 b of the shaft 144extends from a distal end of the curved section 144 a. The curvedsection 144 a and the straight section 144 b are substantially coplanarin a second plane. According to the illustrative embodiment of FIGS.13A-13C, the first and second planes are substantially orthogonal toeach other. However, the first and second planes may be at any suitableangle (e.g., about 10, 20, 30, 45, 60, 70 or 80 degrees) to each other.In another illustrative embodiment of FIGS. 13A-13C, the first andsecond sections 142 a and 142 c of the handle 142 are at an angle ofabout 150 degrees to each other. However, first and second sections 142a and 142 c of the handle 142 may be at any suitable angle (e.g., about80, 90, 100, 110, 120, 130, 140, 160, 170 or 180 degrees) to each other.

To provide structural reinforcement, sections 142 b and 142 c have across sectional diameter that tapers to be smaller at the distal end 143of the handle 142. Additionally, rather than having the tapered section17 c of the transitional portion 17 being formed as part of the shaft14, as shown in FIG. 1, the tapered portions 142 a, 142 b, and 142 c ofthe embodiment of FIG. 13 are formed as part of the handle 142.According to one feature, this configuration reduces the length of thetransitional portion 145 and thus, provides improved structural supportfor the curved section 144 a. Preferably, in operation, neither thehandle 142 nor the transitional portion 145 extends into the body of thepatient, and the angle at transitional portion 145 provides a positivestop against this occurring.

FIG. 14 depicts a variation of the illustrative embodiment of FIGS.13A-13C, wherein the transitional portion 151 of the delivery device 150includes alternative structural reinforcement sections 151 a-151 c. Thetransitional portion 151 functions in similar fashion to the handlesections 142 b and 142 c of FIG. 13 to provide improved structuralsupport to the shaft 154. As shown, the shaft 154 interfits with andextends axially out of the distal end 153 of the second straight section151 c of the transitional section 151. The second straight section 151 cinterfits directly with the curved section of the shaft 154.

FIG. 15 depicts another variation of the illustrative embodiment of FIG.14, wherein a shaft 164, such as the shaft 112 depicted in FIGS. 10A-10Cis affixed to a distal end of a handle 162. In this embodiment, thehandle does not include any distally extending supporting structures,and the shaft 164 has a substantially constant cross sectional diameter.As shown, the delivery device includes a transitional portion 163 havingfirst straight section 163 a extending distally from a distal end of thehandle 162 and along a longitudinal axis 161 of the handle 162. A secondstraight section 163 b of the transitional portion 163 extends distallyfrom, but at an angle to the first straight section 163 a. In theillustrative embodiment, the second straight section 163 b issubstantially coplanar in a first plane with the first straight section163 a. A curved section 164 a of the shaft 164 extends from a distal endof the second straight section 163 b and curves the shaft 164 backtoward the axis 161. A straight section 164 b of the shaft 164 extendsfrom a distal end of the curved section 164 a. The curved section 164 aand the straight section 164 b are substantially coplanar with eachother in a second plane. As in the case of the embodiment of FIGS.11A-11D and as shown in FIG. 15, the first plane of the first 163 a andsecond 163 b straight sections and the second plane of the curvedsection 164 a are angled relative to each other and are not the sameplane.

FIGS. 16A-16D depict various views of another illustrative deliverydevice 170, which illustrates another variation of the illustrativeembodiment of FIGS. 13A-13C. In this variation, the sections of thetransitional portion includes two elbow bends 176 and 178 as opposed tothe single bend depicted in the prior embodiments. With thisconfiguration, and depending on the elbow bends employed, the handle 171and the transitional sections 172 a-172 c may be coplanar, with only theshaft 174 being in a different plane. Alternatively, the transitionalportion 172 may be configured such that one or more of the transitionalsections 172 a-172 c are substantially in a third plane different fromthe plane of the handle 171 and/or the shaft 174.

FIG. 17 depicts another illustrative delivery device 180 configuredsimilarly to the delivery devices of FIGS. 13A-13C. According to anotherfeature of the invention, the delivery device 180 includes a button likefinger support 184 located on a reinforced section 182 c of thetransitional portion 182 for improving a medical operator's grasp of thedevice 180. As in previously discussed embodiments, one or more of thetransitional sections 182 a-182 c may be formed as shaft sections orhandle sections and the button like feature may be located on a sectionof the shaft or handle. The shaft includes a curved section 185 andterminates in a conical tip 186.

FIGS. 18 and 19 depict another variation on the delivery device 180 ofFIG. 17. In this illustrative embodiment, the delivery device 190further includes a distally extending center post 198. To improvevisibility, the center post 198 includes a sighting aperture 199,through which a medical operator can view the position of the shaft 192generally and the conical tip 196 specifically. The post 198 also helpsin orientating and guiding the conical tip 196 through the obturatorforamen. The post 198 may also be used as a rotational and resting pointto stabilize the shaft 192 during tissue penetration. The post 198 mayalso prevent the operator from inadvertently penetrating too deep anddamaging organs and vessels. To open the gap or distance between theconical tip 196 and the alignment post 198, the axial extension of thealignment post 198 may be adjusted.

Any of the delivery devices described above may be used to deliver andplace any suitable implant, such as a sling (e.g., a knitted mesh), or asling assembly, at an anatomical site in a patient's body. Additionally,any suitable mechanism may be employed to associate the sling assemblywith the shaft of the delivery device. In a preferred embodiment, thesling assembly does not affix, attach, connect or join with the shaft ofthe delivery device(s). Instead it hooks onto the delivery device,preferably in a loose and removable fashion.

Without limitation, exemplary sling assembly configurations that may beoperable with illustrative embodiments of the invention may be found inthe patents and patent applications cited herein, and U.S. patentapplication Ser. No. 10/641,170; U.S. patent application Ser. No.10/641,192; U.S. provisional Patent Application Ser. No. 60/495,439,U.S. patent application Ser. No. 10/640,838; U.S. provisional PatentApplication Ser. No. 60/403,555; U.S. provisional Patent ApplicationSer. No. 60/465,722; U.S. patent application Ser. No. 10/460,112; andU.S. patent application Ser. No. 09/096,983, the entire contents of allof which are incorporated herein by reference.

In one exemplary sling assembly, the length of the sling is shorter thanthe length of the sleeve, and the sling does not connect to the sleeveor anything else. The sling assembly inhibits the medical operator fromgripping the free ends of the sling and inadvertently tensioning thesling. This feature may be further enhanced by making the sling longenough to support the urethra but not long enough to expose the ends ofthe sling outside the body. This may have the advantage of preventinginfection caused by the exposure of the sling external to the body. Byway of example, an illustrative sleeve may be at least about 1 cm, 2 cm,3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm longer than thesling. According to other illustrative embodiments, the sleeve may beabout 10 cm, 15 cm, 20 cm, 25 cm, or 30 cm longer than the sling. Inparticular, in transobturator procedures, the sling may be configured tobe long enough to extend to, or through, both the obturator foramen butnot long enough to extend outside of the body. In other embodiments, thesling may be configured in length to extend outside of the body, whenplaced, and the ends then trimmed to length by the physician to a pointjust under the skin.

FIGS. 20A-20D depict various views of an exemplary sling assembly of thetype that may be employed in an illustrative embodiment of theinvention. The sling assembly 210 (referring to FIGS. 20A and 20C)includes a sling 214, illustratively formed from a knitted mesh(referring to FIG. 20B), and a flexible sleeve 212, illustrativelyformed from a flexible polymer plastic (referring to FIGS. 20B and 20C).As depicted in FIG. 20A, the sling 214 is positioned within the sleeve212. As depicted in FIGS. 20A and 20C, each end of the sleeve 212connects to a dilator 211 a or 211 b. The dilators 211 a and 211 b actto secure the association loops 213 a and 213 b, to transition from thesling assembly to the association loops 213 a and 213 b and to expandtissue along a respective path during sling assembly placement.

The sleeve 212 may be made, for example, from one or more absorbentmaterials, such as a sponge-like material, that can optionally bepre-soaked in a drug solution, for example, in an anesthetic,anti-inflammatory, coagulating, anticoagulating, or antibiotic solution.In another embodiment, the sleeve 212 may be made from a non-wettablematerial, such as polypropylene, polyethylene, polyester,polytetrafluoroethylene (available from DuPont Corporation, Wilmington,Del., under the trademark TEFLON®, TYVEK®, MYLAR®, or co-polymersthereof. The non-wettable materials can also be pretreated with atherapeutically effective drug coating. The sleeve 212 is preferablytransparent so that an operator will be able to see the implantablesling 214 inside the sleeve 212.

According to the illustrative embodiment, the knitted mesh 214 is madeentirely of polypropylene, is approximately 1 cm in width and 45 cm inlength, and terminates at free ends. In preferred embodiments, the sling214, including both free ends, does not connect to the sleeve 212 oranything else. This feature enables a medical operator to pull on theends of the sleeve 212 during sling assembly placement, for example, viathe dilators 211 a and 211 b, the association loops 213 a and 213 b,and/or any of the delivery devices to be used for placement, withoutrisk of stretching, curling or otherwise deforming the sling 214.

In certain embodiments, a sling of the invention has a length of about10 to about 15 cm (about 4-6 inches) and a width of about 1 to about 3cm, though the length and width of the sling can be adapted to the bodypart of the patient that requires support. By way of example, in someembodiments the sling 214 is about 45 cm in length. The sling may berectangular or have another suitable shape. The sling may have a uniformthickness over the entire length and/or width of the sling.Alternatively, the thickness can be suitably varied at one or morelocations. The thickness of the sling material may range from about 0.02to about 0.10 cm. In one embodiment, the sling is a strip of mesh withany of a number and/or configurations of knits, weaves, or braids, e.g.,the sling 242 of FIG. 23.

The sling 214 may be fabricated from any of a number of biocompatiblematerials, such as nylon, polyethylene, polyester, polypropylene,fluoropolymers, copolymers thereof, combinations thereof, or othersuitable synthetic material(s). The material may be, for example, asynthetic material that is absorbable by the patient's body. Suitableabsorbable synthetic materials can include polyglycolic acid, polylacticacid, and other suitable absorbable synthetic materials. Alternatively,the material for the sling may be derived from mammalian tissue(s) or acombination of mammalian tissue(s) and synthetic material(s). The slingmaterial may be fabricated from one or more yarns, which yarns may bemade from one or more materials. The sling may incorporate or be coatedwith one or more agents to provide a therapeutic effect, for example, toreduce discomfort, to reduce the chance of infection and/or to promotetissue growth.

In one embodiment, the edge regions of the sling can be configureddifferently depending on their intended placement in the body of thepatient. For example, a midsection of the sling is typically locatedwhere an anatomical site, such as a mid-urethral or bladder necklocation in the periurethral tissue, needs to be supported. In oneillustrative embodiment, the midsection of the sling has smooth orrounded edges, hereinafter also referred to as “non-tanged” or“de-tanged.” According to a further illustrative embodiment, othersections of the sling may include tangs (e.g., sharp projections orfrayed edges). The tangs are generally useful for anchoring the sling214 and/or encouraging tissue growth into the sling. Anchoring the slingin this manner generally obviates the need for additional sutures tohold the sling in place.

The tanged and non-tanged edges of sling can be formed in a plurality ofways. For example, the sling can be cut from a woven sheet, in whichcase the edges would be initially tanged along the entire length of thesling. One or more nontanged sections may be formed by any process thatsmoothes, rounds or removes the sharp edges of the tangs. For example,the tangs may be heat-smoothed by burning or melting the tangs. In oneembodiment, the nontanged section has a length of about 1 to about 5 cm,preferably about 2 to about 2.5 cm, on either or both sides of thecenter line of the sling. Providing one or more non-tanged sections,which may be in close proximity to a sensitive anatomical site in thepatient, can enhance the comfort level of the patient and reduce thepotential for the edges of the tangs to erode or irritate the urethra.Alternatively, the sling can be produced from a woven tape having theapproximate finished width of the sling. The smooth sides of the tapecan then be trimmed off to produce the tanged sections.

Referring to FIG. 20B, an opening 216, located at a midpoint of a topportion 212 a of the sleeve 212, exposes the entire width of the sling214. A tabbed spacer 218 is located at a midpoint of a bottom side 212 bof the sleeve 212, and encloses a looped portion 219 of the bottom side212 b of the sleeve 212. The tabbed spacer 218 can be used duringimplantation as a visual aid to placement of the sling 214. The tabbedspacer 218 also engages the looped portion 219 of the bottom side 212 bof the sleeve 212 and prohibits the sleeve 212 from sliding off, orotherwise being removed from, the sling 214 during sling assemblyplacement. Preferably, the tabbed spacer 218 must be cut to enable thesleeve 212 to slide off the sling 214. This feature ensures that thesleeve 212 cannot be removed simply by applying a pulling force, such asthat applied to the sling assembly ends by a medical operator duringsling assembly placement. After the sling assembly is positioned withinthe patient, a cut is made through the center of the tabbed spacer 218,and thus through the looped portion 219 of the bottom side 212 b of thesleeve 212. The sleeve 212 is then slid off of the sling 214, out of thebody of the patient, and discarded, along with the dilators 211 a and211 b.

FIG. 21 is a longitudinal cross sectional view of a dilator and anassociation loop according to an illustrative embodiment of theinvention. As depicted, the dilator 211 a is preferably a rigid polymertube of approximately 2 cm in length terminating in a conical tip.Embedded and secured along the length of the dilator 211 a are two endsof a wire 222 formed from twisted metal strands. The wire 222 extendsfrom the conical tip of the dilator 211 a to form an association loop213 a. The association loop 213 a extending from each conical tip ispreferably approximately 15 mm in length. The association loop 213 a ispreferably deformable, but generally shape-retaining. Preferably, thedilator 211 b and the association loop 213 b, as depicted in FIGS.20A-20C, have substantially the same configurations as the dilator 211 aand the association loop 213 a, respectively.

FIG. 22 is a side view of an L-slot in a distal end of a shaft of adelivery device according to an illustrative embodiment of theinvention. For example, an L-slot 232 is preferably positioned on thedistal end 19 of the shaft 14 as depicted in FIG. 1. Referring to FIG.22, the L-slot 232 is preferably formed from a first channel 232 aapproximately 2 mm in length and 1 mm in width extending radially intothe shaft 230 and a second channel 232 b approximately 5 mm in lengthand 1 mm in width extending distally along the length of the distal end231 of the shaft 230 from an inner terminal end of the first channel 232a. As discussed in more detail below, in certain illustrativeembodiments, the first association loop 213 a slides radially into thefirst channel 232 a and along the second channel 232 b to hook one endof the sling assembly onto the distal end 231 of the shaft 230 of adelivery device. This process may be repeated with the secondassociation loop 213 b and the same (after unhooking the firstassociation loop 213 a off the delivery device) or a second deliverydevice.

An advantage of the L-slot 232 configuration is that the associationloops 213 a and 213 b remain free to slide along the respective secondchannels 232 b. When slid to a proximal most position in the respectivesecond channels 232 b, the association loops 213 a and 213 b may be slidradially out of the respective first channels 232 a to unhook the slingassembly from the delivery device(s) with a minimum of effort.Alternatively, during withdrawal of the delivery device(s), the distallyextending orientation of the respective second channels 232 b causes theassociation loops 213 a and 213 b to slide to the distal most positionsin the respective L-slots 232. This tends to maintain the associationloops 213 a and 213 b, and thus the sling assembly, hooked onto therespective second channels 232 b during withdrawal of the deliverydevice(s).

In some alternative configurations, the second channel of an L-slotextends proximally, rather than distally, along the distal end of ashaft of any delivery device of the invention. An L-slot may bepreferably formed from a first channel approximately 2 mm in length and1 mm in width extending radially into the shaft, and a second channelapproximately 5 mm in length and 1 mm in width extending proximallyalong the length of the distal end from an inner terminal end of thefirst channel. When pushing or inserting the shaft of the deliverydevice into the body of a patient, the proximally extending orientationof the second channel causes the association loops, for example theassociation loop 213 a as depicted in FIG. 21, to slide to a proximalmost position in the L-slot. This tends to maintain the associationloop, and thus the sling assembly comprising the association loop,hooked onto the second channel during insertion of the shaft of thedelivery device into the body.

In some configurations, the first channel of the L-slot extends into theshaft from radially inner location along the surface of the shaft.However, in other embodiments, the first channel of the L-slot extendsinto the shaft from a radially outer surface of the shaft. Additionally,the arrangement by which the sling assembly is associated with the shaftend can take numerous other forms as known in the art.

FIG. 23 depicts a sling assembly 240 according to an alternativeembodiment of the invention. The sling assembly 240 includes the guidetubes 249 a and 249 b at respective ends of the sleeve 244. The guidetubes 249 a and/or 249 b may taper in a direction toward or away fromthe midpoint of the sling assembly 240 depending on into which end ofthe guide tube a delivery device shaft is to be inserted. The guidetubes may be affixed to the sling assembly ends by any suitablemechanism, including gluing, heat bonding, shrink tubing or the like. Incertain embodiment, the guide tubes 249 a and 249 b are designed toslide onto the shaft of a delivery device of the invention, andpreferably the inner diameter of the guide tube is larger than thediameter(s) of the curved shaft or the diameter(s) of at least onesection of the shaft, e.g., the distal end of the shaft.

FIGS. 24A and 24B depict two illustrative examples of how the guidetubes 249 a and 249 b may be slid onto the shaft 252 of a deliverydevice. As depicted in FIG. 25A, according to one approach, the conicaltip 254 is inserted into the end 256 of the guide tube 249 a not bondedto the sleeve 244 a of the sling assembly 244. As depicted in FIG. 25B,in an alternative embodiment, the conical tip 254 of the shaft 252 isinserted into the guide tube end 255 that is bonded to the sleeve 244 aof the sling assembly 244. Preferably, the guide tube 249 a slideseasily on and off the shaft 252 of the delivery device. However, inalternative embodiments, the sling assembly ends may include receptacleconnectors or mating structures, for forming a secure attachment betweenthe sling assembly end and the distal end of the delivery device shaft.

Described now with respect to FIGS. 25A-25C are various illustrativemethods for delivering an implant, such as a sling or sling assembly, toan anatomical site in the body of a patient. The illustrative methodsinclude trans-obturator approaches. Other approaches, such as forexample suprapubic, prepubic, and transvaginal approaches are disclosedin the patents and patent applications cited herein. All operativecombinations between the disclosed delivery devices and thesealternative procedures are contemplated. Any of the delivery devicesdescribed above may be employed to create a passage through body tissue,for example, from the inferior pubic ramus through the obturator foramento the vagina or the reverse according to the methodologies describedherein.

According to one exemplary methodology, referring to FIG. 25A, a firstincision 271 b is made on the inside of the patient's thigh, forexample, about 1 cm outside the external margin of the labia majora. Themedical operator inserts the shaft 267 of the delivery device 268, tipfirst, into the first incision 271 b and continues to penetrate a firstobturator foramen 263 b. With a rotating wrist motion, the shaft 267 isguided along the posterior ischiopubic ramus to a vaginal incision 266on the vaginal wall 275. After a distal portion 265 of the shaft 267emerges out of the vaginal wall 275, the operator associates a distalend of the shaft 267 with a first end of a sling assembly 210.

According to one illustrative embodiment, the distal end of the shaft267 includes an L-slot onto which an association loop located at thefirst end of the sling assembly may be hooked. More particularly, andalso with reference to FIGS. 20A-22, a first association loop, such asthe association loop 213 a is slid over the distal end 265 of the shaft267 of the delivery device and radially into a first channel, such asthe channel 232 a of an L-slot, such as the L-slot 232. The associationloop 213 a is then moved distally away from the delivery device within asecond channel, such as the channel 232 b, to hook one end of the slingassembly onto the delivery device. The delivery device is then withdrawnfrom the ishiopubic incision, drawing the end of the sling assemblythrough the passage created by the shaft 267. The orientation of theL-slot 232 with respect to the ishiopubic approach ensures that theassociation loop 213 a is tensioned toward the closed, distal end of theL-slot 232 as the delivery device is withdrawn. Subsequent towithdrawal, the association loop 213 a and the distal end 265 of theshaft 267 are oriented perpendicularly to each other, and then theassociation loop 213 a is unhooked from the delivery device.

The process can then be repeated with the same or a second deliverydevice on the contralateral side of the body with a second associationloop, such as the association loop 213 b of the sling assembly 210.Optionally, a single cystoscopy may be performed with two deliverydevices in place, prior to withdrawal of the delivery devices to verifyintegrity of the bladder. Cystoscopy could also be performed, asdesired, after each placement of a delivery device on a side of thebody.

Referring also to FIG. 24A, in an alternative approach, a guide, such asthe guide tubes 249 a or 249 b, extends from each sling assembly end 262a and 262 b. The guide tube can be slid over the distal end 265 of theshaft 267 according to the approach of FIG. 24A. Then, the operatorwithdraws the shaft 267 of the delivery device back out of the obturatorforamen 263 b, bringing the sleeve end 244 a or 244 b of the slingassembly 240 out of the first thigh incision 271 b.

Once again, the process can then be repeated with the same or a seconddelivery device on the contralateral side of the body with a secondassociation guide tube. Optionally, a single cystoscopy may be performedwith two delivery devices in place, prior to withdrawal of the deliverydevices to verify integrity of the bladder. Cystoscopy may also beperformed, as desired, after each placement of a delivery device on aside of the body. FIG. 25C provides a conceptual drawing showing thesling assembly positioned prior to cutting the tabbed divider 218. Oncedesired placement of the sling assembly is achieved, the tabbed spacer218, and thus the looped portion 219 of the bottom side 212 b of theplastic sleeve 212, is cut. Then, by pulling on the dilators or guidetubes, as the case may be, the medical operator can slide the sleeve 212off the sling 214 and remove it from the body. The delivery device(s)and the plastic sleeve 212, including the dilators or the guide tubes,as the case may be, may then be discarded. In some embodiments the slingends are anchored or otherwise affixed to muscle, tissue, or bone withinthe pelvic region of the body. However, in preferred embodiments, thesling ends remain unanchored.

Referring to FIG. 25B, in an alternative embodiment, the operator canreverse the direction in the trans-obturator approach by starting from avaginal incision 266 and tunneling through the obturator foramen 263 aor 263 b to the respective thigh incision 271 a or 271 b using any ofthe delivery devices and sling assemblies described above.

According to one illustrative embodiment, the distal end of the shaft267 includes an L-slot onto which an association loop located at thefirst end of the sling assembly may be hooked. According to embodiment,the L-slot orientation is such that the second channel of the L-slotextends proximally along the shaft, as opposed to distally. Withreference to FIGS. 20A-22, prior to inserting the shaft into the vaginalincisions, a first association loop, such as the association loop 213 ais slid over the distal end 265 of the shaft 267 of the delivery deviceand radially into a first channel, such as the channel 232 a of anL-slot, such as the L-slot 232. The association loop 213 a is then movedproximally toward the delivery device within a second channel, such asproximally extending variation of the distally extending channel 232 b,to hook one end of the sling assembly onto the delivery device. Thedelivery device is then inserted through the vaginal incision and outthe ishiopubic incision, as described above. The orientation of theL-slot 232 with respect to the vaginal approach ensures that theassociation loop 213 a is tensioned toward the closed, proximal end ofthe L-slot 232 as the delivery device is inserted into the vaginalincision and out the ishiopubic incision. After the distal tip of thedelivery device exits the ishiopubic incision, the association loop 213a and the distal end 265 of the shaft 267 are oriented perpendicularlyto each other, and then the association loop 213 a is unhooked from thedelivery device. The delivery device can then be withdrawn.

The process can then be repeated with the same or a second deliverydevice on the contralateral side of the body with a second associationloop, such as the association loop 213 b of the sling assembly 210 inFIG. 20A. Optionally, a single cystoscopy may be performed with twodelivery devices in place, prior to withdrawal of the delivery devicesto verify integrity of the bladder. Cystoscopy could also be performed,as desired, after each placement of a delivery device on a side of thebody. Alternatively, cystoscopy could be performed after withdrawal ofthe delivery devices.

Referring also to FIG. 24B, in an alternative approach, a guide, such asthe guide tubes 249 a or 249 b, depicted in FIG. 23, extends from eachsling assembly end 242 a and 242 b. The guide tube can be slid over thedistal end 265 of the shaft 267 according to the approach of FIG. 25B.Then, the operator inserts the shaft 267 of the delivery device into thevaginal incision as described above with respect to FIG. 25B. Accordingto this embodiment, once the distal end 265 of the shaft 267 exits theishiopubic incision, a medical operator can grasp the guide tube andwithdraw the delivery device. It should be noted that the guide tubes ofthis embodiment are particularly sized to enable the distal tip 265 ofthe shaft 267 to extend out and be exposed, when inserted.

As in the above described methodologies, the process can then berepeated with the same or a second delivery device on the contralateralside of the body with a second association guide tube, such as the guidetube 249 b as depicted in FIG. 23. Optionally, a single cystoscopy maybe performed with two delivery devices in place, prior to withdrawal ofthe delivery devices to verify integrity of the bladder. Cystoscopycould also be performed, as desired, after each placement of a deliverydevice on a side of the body. Alternatively, cystoscopy could beperformed after withdrawal of the delivery devices.

Variations, modifications, and other implementations of what isdescribed may be employed without departing from the spirit and thescope of the invention. More specifically, any of the method, system anddevice features described above or incorporated by reference may becombined with any other suitable method, system or device featuresdisclosed herein or incorporated by reference, and is within the scopeof the contemplated inventions.

What is claimed is:
 1. A system for treating urinary incontinence,comprising: a flexible sleeve having a first end and a second end; amesh sling at least partially within the sleeve, the mesh sling beingplanar and defining a longitudinal axis and a transverse axis, the meshsling being longer on the longitudinal axis than the transverse axis; afirst guide tube attached to the first end of the sleeve and a secondguide tube attached to the second end of the sleeve, each of said firstand second guide tubes comprising a tapering cylindrical portion, thefirst guide tube defining a first lumen having a longitudinal axis thatis parallel with the longitudinal axis of the mesh sling, and the secondguide tube defining a second lumen having a longitudinal axis that isparallel with the longitudinal axis of the mesh sling; and a deliverydevice comprising: a handle; a shaft having a curved portion terminatingin a substantially conical tip, at least the first guide tube beingconfigured to receive the shaft at a first end of the first guide tubethat is coupled with the sleeve such that a portion of the shaft isdisposed with first guide tube and the conical tip extends out of asecond end of the first guide tube; and first and second straightsections, the first straight section extending along a first axis andthe second straight section extending along a second axis different fromthe first axis.
 2. The system of claim 1, wherein an inner diameter ofeach of the first and second guide tubes is greater than an outerdiameter of the conical tip.
 3. The system of claim 1, furthercomprising first and second receptacle connectors disposed at the firstand second ends of the sling, respectively.
 4. The system of claim 1,further comprising first and second mating structures disposed at thefirst and second ends of the sling, respectively.
 5. The system of claim1, wherein the sleeve includes a tab attached intermediate to first andsecond ends of the sleeve, the sleeve being removable to expose the meshsling by cutting the tab.
 6. The system of claim 1, wherein sleeve islonger than the sling.
 7. The system of claim 6, wherein the sleeve isabout 10 cm longer than the sling.
 8. The system of claim 6, wherein thesleeve is about 20 cm longer than the sling.
 9. The system of claim 6,wherein the sleeve is about 30 cm longer than the sling.
 10. The systemof claim 1, wherein the delivery device includes a transitional portionlocated intermediate to the handle and the shaft for affixing the shaftto the handle.
 11. The system of claim 10, wherein at least part of thetransitional portion is formed as part of the shaft.
 12. The system ofclaim 10, wherein at least part of the transitional portion is formed aspart of the handle.
 13. A system for treating urinary incontinence,including: a delivery device having: a handle; and a shaft having afirst curved portion and a substantially conical tip at a distalterminus of the shaft; and a sling assembly, including: a mesh sling,the mesh sling being planar and defining a longitudinal axis and atransverse axis, the mesh sling being longer along the longitudinal axisthan the transverse axis; a flexible sleeve at least partially enclosingthe mesh sling, the flexible sleeve including: first and second guidetubes disposed at first and second ends of the flexible sleeve,respectively; and a tab attached intermediate to the first and secondends of the sleeve, the sleeve being removable to expose the mesh slingby cutting the tab, at least the first guide tube having a first endcoupled with the sleeve, a second end, and a lumen extendingtherethrough, the lumen defining a longitudinal axis that is parallelwith the longitudinal axis of the mesh sling and configured to receiveat least a portion of the shaft.
 14. The system of claim 13, wherein thefirst and second guide tubes are substantially cylindrical.
 15. Thesystem of claim 13, wherein the first and second guide tubes aretapered.
 16. The system of claim 13, further comprising first and secondmating structures disposed at the first and second ends of the sling,respectively.
 17. The system of claim 13, wherein sleeve is longer thanthe sling.
 18. The system of claim 17, wherein the sleeve is about 10 cmlonger than the sling.
 19. The system of claim 17, wherein the sleeve isabout 20 cm longer than the sling.
 20. The system of claim 17, whereinthe sleeve is about 30 cm longer than the sling.
 21. The system of claim13, further comprising first and second receptacle connectors disposedat the first and second ends of the sling, respectively.